Geneva, 14 December 2015 Funding Opportunity RFA-FD-15-014 Project Summary International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an international non-profit organisation the purpose of which is to promote public health through international harmonisation of technical requirements that contributes to the timely introduction of new medicines and continued availability of the approved medicines to patients, to the prevention of unnecessary duplication of clinical trials in humans, to the development, registration and manufacturing of safe, effective, and high quality medicines in an efficient and cost- effective manner, and to the minimisation of the use of animal testing without compromising safety and effectiveness. A major output of ICH's work is the development of harmonised technical guidelines on Quality, Safety and Efficacy topics. The ICH Guidelines represent agreed-upon scientific guidance for meeting technical requirements for registration of pharmaceutical products within the European Union, Japan, USA, Canada, Switzerland and beyond. Each ICH Regulatory Member implements the ICH Guidelines according to its national/regional requirements. To-date over 60 harmonised ICH Guidelines on Safety, Quality and Efficacy topics, as well as Multidisciplinary topics have been developed.